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NCT05688215 · ClinicalTrials.gov registry record · Phase 1

Zimberelimab and Quemliclustat in Combination With Chemotherapy for the Treatment of Patients With Borderline Resectable and Locally Advanced Pancreatic Adenocarcinoma

A Phase 1 study of Borderline Resectable Pancreatic Adenocarcinoma and Locally Advanced Pancreatic Ductal Adenocarcinoma, sponsored by Jonsson Comprehensive Cancer Center.

Recruiting
Registry status
Phase 1
Development phase
56
Enrollment target
1
Study location

NCT05688215: Recruiting Phase 1 study of Borderline Resectable Pancreatic Adenocarcinoma and Locally Advanced Pancreatic Ductal Adenocarcinoma, sponsored by Jonsson Comprehensive Cancer Center.

NCT05688215 is a Phase 1 study of Borderline Resectable Pancreatic Adenocarcinoma and Locally Advanced Pancreatic Ductal Adenocarcinoma that is actively recruiting participants, run by Jonsson Comprehensive Cancer Center. The registered enrollment target is 56 participants, above the 43-participant average among 7 other Borderline Resectable Pancreatic Adenocarcinoma trials with a reported enrollment target (30% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05688215, a Phase 1 study of Borderline Resectable Pancreatic Adenocarcinoma and Locally Advanced Pancreatic Ductal Adenocarcinoma, is actively recruiting participants, sponsored by Jonsson Comprehensive Cancer Center.

RECRUITING
Registry status
Phase 1
Development phase
56 participants
Enrollment target
1
Study location

Study Summary

This phase I/II study tests how well zimberelimab and quemliclustat work in combination with chemotherapy (mFOLFIRINOX) in treating patients pancreatic adenocarcinoma that may or may not be able to be removed by surgery (borderline resectable) or that has spread to nearby tissue or lymph nodes (locally advanced). Immunotherapy with monoclonal antibodies, such as zimberelimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Quemliclustat acts as a blocker for adenosine. Adenosine is a chemical produced in the body that can lead to a decrease in the immune system's response towards cancer. Quemliclustat has the potential to decrease the amount of adenosine, allowing the immune system to recognize and act against the cancer. Chemotherapy drugs, such as oxaliplatin, irinotecan, leucovorin, and fluorouracil, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy in combination with zimberelimab and quemliclustat may kill more cancer cells than chemotherapy alone.

Primary Outcome

All safety summaries and analyses will be based upon the Safety Population, as defined in this study protocol, will include all randomized participants who receive at least 1 dose of any study drug. Overall exposure to study drug, the numbers of participants completing each cycle, and the dose intensity will be summarized using descriptive statistics. The number of participants with any dose adjustment will be presented for entire treatment period as well as for each cycle. The number of partici

Conditions Studied

Borderline Resectable Pancreatic Adenocarcinoma Locally Advanced Pancreatic Ductal Adenocarcinoma

Interventions

  • PROCEDURE Biospecimen Collection
  • PROCEDURE Computed Tomography
  • DRUG Fluorouracil
  • DRUG Irinotecan
  • PROCEDURE Core Biopsy

Study Locations (1)

California

  • Yonemoto,Lisa - Los Angeles

Trial Details

FieldValue
Enrollment Target 56 participants
Start Date 2023-03-07
Est. Completion 2027-03-02
Phase Phase 1
Jonsson Comprehensive Cancer Center

321 total trials

What NCT05688215 shows while recruiting

NCT05688215 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, above the 43-participant average among 7 other Borderline Resectable Pancreatic Adenocarcinoma trials with a reported enrollment target (30% higher).

The record links to 2 conditions, with Borderline Resectable Pancreatic Adenocarcinoma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.

NCT05688215 reports a single indexed study location in California.

Frequently Asked Questions

What is clinical trial NCT05688215 about?

NCT05688215 is a clinical study titled "Zimberelimab and Quemliclustat in Combination With Chemotherapy for the Treatment of Patients With Borderline Resectable and Locally Advanced Pancreatic Adenocarcinoma". This phase I/II study tests how well zimberelimab and quemliclustat work in combination with chemotherapy (mFOLFIRINOX) in treating patients pancreatic adenocarcinoma that may or may not be able to be removed by surgery (borderline resectable) or that has spread to nearby tissue or lymph nodes (loca...

What is the current status of trial NCT05688215?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 56 participants. The study started on 2023-03-07. Estimated completion is 2027-03-02.

What conditions does trial NCT05688215 study?

This clinical trial studies the following conditions: Borderline Resectable Pancreatic Adenocarcinoma, Locally Advanced Pancreatic Ductal Adenocarcinoma.

What interventions are being tested in trial NCT05688215?

The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Fluorouracil (DRUG), Irinotecan (DRUG), Core Biopsy (PROCEDURE).

Who is sponsoring clinical trial NCT05688215?

This trial is sponsored by Jonsson Comprehensive Cancer Center, which has 321 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05688215 being conducted?

This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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More recruiting context for NCT05688215

Source: ClinicalTrials.gov NCT05688215, the US trial registry maintained by the National Library of Medicine. NCT05688215 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.